- Merck & Co. (Rahway, NJ)
- …customer requirements. --Principal ResponsibilitiesLead/contribute to device development, design controls and risk management strategy for the assigned ... Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy , Design Controls and Risk Management Our… more
- Eisai, Inc (Nutley, NJ)
- …IT business stakeholders on business continuity, governance, and audits.Manage global IT Risk Management Procedure and third-party risk assessments.Establish ... teams in the execution of Risk and Compliance initiatives and support professional growth. Risk Management : Develop and manage global risk management … more
- Merck & Co. (Rahway, NJ)
- … requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and development ... to the strategic direction of the company's product pipeline and regulatory strategy .Drive operational excellence initiatives that improve quality, compliance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Lot Distribution Data (LDD), etc.) and that is in alignment with the regulatory strategy . This individual works cross-functionally with internal and external ... Regulatory Affairs labeling related issues. Relationships Reports to labeling management in Regulatory Operations and Innovation. Develop and maintain… more
- Genmab (Plainsboro, NJ)
- …record of applying data quality methodologies to enhance business operations, risk management , and decision-making processes.Strong leadership and communication ... our Business Information Services as the Director of Data Stewardship and Data Strategy . This crucial position involves guiding Data policies and actions across the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... impact assessments to ensure documentation is available for audits and inspections Management Strategy and Goals:Assist in developing PV goals, continued… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... and mentor talentStrategic and critical thinking to advance biopharmaceutics strategy across the portfolioProject management skillsAttention to technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical ... with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the cross functional teams, to influence and ensure that the development-, regulatory and or medical strategy and procedures are aligned with the ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...reporting regulations, Health Canada regulations ICH guidelines and the management of contracts with safety reporting requirements. Key contact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Genmab (Plainsboro, NJ)
- …of corresponding actions and processes.Knowledge/SkillsExcellent knowledge of security and risk management frameworks and standards (eg NIST, ISO).Excellent ... with strategic / tactical responsibilitiesFive or more years of management responsibilities, including strategy , budgeting and staffing.Demonstrated experience… more
- Aequor (Thousand Oaks, CA)
- …and processes in collaboration with Process Development and other functions; Strategy Management , Analytics, Business Development (Client), and Governance, ... to call will be shortlisting EOD Wednesday 11/13 Operations Strategy & Business Resilience (OSBR) is a diverse internal... & Business Resilience (OSBR) is a diverse internal management consulting arm of Operations that serves as trusted… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and the ability to work in teams-displays initiative and commitment Engineering and risk -based management within an FDA, EMEA, GMED or TGA regulated production ... for biotechnology manufacturing. This individual is responsible for the creation, management and execution of engineering life cycle documentation and verification… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market dynamics. It will also include commercial ownership of portfolio level device strategy and lifecycle management of devices. Relationships Reports to the ... (MAPA), to co-create strategies for a cohesive portfolio planning, device strategy and indication management . Facilitate communication and coordination across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Serves ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
